Hobbs Posi-Stop Injection Needle
A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection,…
A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.
23manufacturers in China registered for this device type
18catalogue numbers in this listing
15recalls on this code
Who Else Makes It
Concentrated in Zhejiang (10), Jiangsu (8), Shanghai (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 23. All 23 manufacturers in China registered for Endoscopic Injection Needle, Gastroenterology-Urology
Record
| Listed by | Hobbs Medical, Inc., United States |
|---|---|
| FDA product code | FBK |
| Device type | Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| 510(k) | K834403 |
| Record published | 2016-09-21 |
| Record revised | 2025-11-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-11-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4714 | In distribution | |
| 4723 | In distribution | |
| 4712 | In distribution | |
| 4708 | In distribution | |
| 4702 | In distribution | |
| 4718 | In distribution | |
| 4722 | In distribution | |
| 4714S | In distribution | |
| 4716 | In distribution | |
| 4706 | In distribution | |
| 4720 | In distribution | |
| 4704 | In distribution | |
| 4721 | In distribution | |
| 4712S | Withdrawn | |
| 4720S | Withdrawn | |
| 4712S-01 | Withdrawn | |
| 4714S-01 | Withdrawn | |
| 4718S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sclerotherapy needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 248 |
| Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 150 |
| Single Use Injector | Olympus Medical Systems Corp. | 91 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Hangzhou AGS MedTech Co., Ltd. | 90 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 90 |
| Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 62 |
| Disposable Injector NM | Olympus Medical Systems Corp. | 46 |
| Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 33 |
| Cook | Cook Incorporated | 25 |
| Injectra, Sclero Tip | Medi-Globe Gmbh | 14 |
| MT | Micro-Tech (Nanjing) Co., Ltd. | 12 |
| Alton | Alton Shanghai Medical Instruments Co Ltd | 12 |
Showing 12 of 58. All products under Endoscopic Injection Needle, Gastroenterology-Urology
Recalls Naming This Product
15 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 70 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 45 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 6 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 5 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 15 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 6 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 12 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 198 units |
| Hobbs Medical, Inc. | 510(k) number | 2024-10-04 | Class II | Process change control | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | 10 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 8 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 7 units |
| Hobbs Medical, Inc. | UDI-DI | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 6 units |
| Hobbs Medical, Inc. | UDI-DI | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 30 units |
| Hobbs Medical, Inc. | UDI-DI | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 50 units |
| Hobbs Medical, Inc. | UDI-DI | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 17 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.